The following data is part of a premarket notification filed by Sectra-imtec Ab with the FDA for Wise (ii) Image Management System.
| Device ID | K983447 |
| 510k Number | K983447 |
| Device Name: | WISE (II) IMAGE MANAGEMENT SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | SECTRA-IMTEC AB 6741 GRANT LN. Plano, TX 75024 |
| Contact | Herman Oosterwijk |
| Correspondent | Herman Oosterwijk SECTRA-IMTEC AB 6741 GRANT LN. Plano, TX 75024 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-10-29 |
| Summary: | summary |